MAUDE Adverse Event Report: CONVATEC

Model Number	510828
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: cure twist® ¿ ready to use catheter for women.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
Event or Problem Description
End user reports unknown number of t14 catheters, unknown number of market units with unknown lot numbers of the same catheter over the last 3 months.Lots unknown - the caps are very difficult to untwist and made her concerned they were defected possibly unsterile and contributed to a uti she has had this month.Consumer states she has had various qty from various mu boxes over the last 3 months from her shipment where "some, just a few enough to be concerning" the caps where really hard to untwist.She said she has no more like this as the last boxes she has used have no defects.She said she was eventually able to untwist them, all but 1, as she said she is very strong and active for 73 years old.She said she has been using these catheters for a very long time and prefers them over any others and has never had this problem before.She loves the portability, their blue color, and they are pre-lubricated.She caths 4 x a day for bladder muscle dysfunction from retention.She said there were no visual abnormalities on these catheters that showed the defect, it was only when she went to untwist them.They were also normal when she finally opened them.She said she is prone to utis and had 2 recent back to back infections this month of september and is currently taking an antibiotic now, cephalexin.She said she thought maybe this defect signaled the catheters were unsterile in some way.She said "it may be one of the reasons maybe not at all" that could have contributed to her utis.She said earlier this month she had a lot of pain in her bladder, urethra, urgency and burning so she went to a "stand alone er" affiliated with a hospital to be seen and get antibiotics.She said she did urine testing which showed uti and was prescribed pyridium and a course of treatment course of nitrofurantoin.She said she had been previously prescribed prophylactic nitrofurantoin 50mg she was to take twice a day to prevent utis but she had not been taking those as prescribed prior to this uti as she said she thought she was doing good not having had a uti since jan 2022.She took the full course of nitrofurantoin however she didn't feel like the uti went away and so her md prescribed her another antibiotic cephalexin which she is taking now.She is aware after she finishes this new treatment course she will have to return to taking her prophylactic antibiotic.She also states she is not good about washing her hands prior to cathing, she was appreciative of the reminder.She is an lpn as well.She said sometimes she is in a rush and will "wipe rough" her urethra with either a baby wipe or cottonelle flushable wipes which she states can cause urethritis.

• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15676352
• Report Number: 1049092-2022-00382
• Device Sequence Number: 6348620
• Product Code: KOD
• UDI-Device Identifier: 00815947020390
• UDI-Public: 815947020390
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 510828
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female